Temporal Pattern of Circulating DNA for Patients Receiving Irradiation

May 29, 2015 updated by: Michael Milano, MD,PhD, University of Rochester

Temporal Pattern of Circulating DNA for Patients Receiving Total Body Irradiation

The purpose of the research study is to test a measurement tool that will determine the radiation dose people receive when they have been accidentally exposed to radiation. This test will be done using a small amount of blood and known dose of radiation.

Study Overview

Status

Terminated

Conditions

Study Type

Observational

Enrollment (Actual)

13

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Rochester, New York, United States, 14642
        • University of Rochester

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients receiving large volume of radiation for the treatment of their cancer

Description

Inclusion Criteria:

  • Patient must be scheduled to undergo Total Body Irradiation (TBI) as part of a conditioning regime for a Bone Marrow Transplant. OR, Be scheduled to undergo Radiation Therapy treatment for a malignancy or other disease and have a radiation treatment field that contains at least 2 liters of tissue receiving at least 2 Gy radiation dose over the first 5 days of treatment.
  • Patient must be willing to have blood draws as defined below.
  • Patient must provide study-specific informed consent prior to study entry.
  • Hemoglobin≥8.
  • Age ≥ 18, but not older than age 60.

Exclusion Criteria:

  • Patients not meeting the above inclusion criteria.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Rochester

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2010

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

April 2, 2010

First Submitted That Met QC Criteria

April 5, 2010

First Posted (Estimate)

April 6, 2010

Study Record Updates

Last Update Posted (Estimate)

June 2, 2015

Last Update Submitted That Met QC Criteria

May 29, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • ULAB10008

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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